Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases
NCT ID: NCT02179372
Last Updated: 2016-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2014-06-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Eicosapentaenoic acid
Subject with Cronn's Disease and/or Ulcerative colitis in clinical remission will receive 2 g/day of eicosapentaenoic acid for 6 months
Eicosapentaenoic acid
30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value \>150 μg/g will recive 2 g/day of Eicosapentaenoic acid for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured. The effect of Eicosapentaenoic acid on fecal calprotectin level will be monitored. Clinical relapses will be considered during the study.
Medium chain fatty acid (placebo)
Subjects with Crohn's Disease and/or Ulcerative colitis will be receive 2 g/day of medium chain fatty acid for 6 months
Medium chain fatty acid (placebo)
30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value \>150 μg/g will recive 2 g/day of medium chain fatty acids for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured.
Interventions
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Eicosapentaenoic acid
30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value \>150 μg/g will recive 2 g/day of Eicosapentaenoic acid for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured. The effect of Eicosapentaenoic acid on fecal calprotectin level will be monitored. Clinical relapses will be considered during the study.
Medium chain fatty acid (placebo)
30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value \>150 μg/g will recive 2 g/day of medium chain fatty acids for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with Ulcerative Colitis (diagnosed on the base of clinic, endoscopic and histologic criteria) in clinical remission (SCCAI = 0) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
* Patients affected by Crohn's Disease (diagnosed on the base of clinic, endoscopic and histologic criteria) ) in clinical remission (CDAI \< 150) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
* Fecal calprotectin at baseline \> 150 μg/g.
Exclusion Criteria
* Patients on steroid therapy.
* Patients in therapy wih warfarin or other anticoagulants.
* Known or supposed ipersensitivity to eicosapentaenoic acid/omega 3.
* Women in fertile age which refuse to use contracceptives specified in the study (oral contraception, IUD) and breastfeed women.
* Patients with severe clinical conditions which the investigator consider to controindicate patient partecipation at the study.
* Therapy modifications and/or assumption of sperimental therapies within three months before the study inclusion.
* Patients unable to follow protocol procedures and to sign the informate consent.
18 Years
80 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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andrea belluzzi, MD phD
Consultant in Gastroenterology
Locations
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Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Bologna, Italy
Countries
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References
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Scaioli E, Sartini A, Bellanova M, Campieri M, Festi D, Bazzoli F, Belluzzi A. Eicosapentaenoic Acid Reduces Fecal Levels of Calprotectin and Prevents Relapse in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1268-1275.e2. doi: 10.1016/j.cgh.2018.01.036. Epub 2018 Jan 31.
Other Identifiers
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EPA/CALPRO
Identifier Type: -
Identifier Source: org_study_id